Methods and systems for the sterilization of endoscopes

ABSTRACT

A method and device for high-pressure, high-temperature steam sterilization of endoscopes includes pressure resistant fittings to attach a steam generator to the ports of an endoscope. The method and device allows for high-pressure, high-temperature steam to circulate throughout the endoscope, exposing various surfaces to steam for sterilization. The method and device also allows for high-pressure, high-temperature steam to circulate selectively through the channels of the endoscope, selectively sterilizing the channels and allowing for use of this method with current high-level disinfection methods. The method and device also allows for movement of the scope elevator channel during the sterilization process, allowing for steam to reach the crevices around the elevator and other moving parts of an endoscope.

CROSS-REFERENCE

The present application is a division application of U.S. patentapplication Ser. No. 15/155,029, entitled “Method and System for SteamSterilization of Endoscopes” and filed on May 15, 2016, which relies onU.S. Provisional Patent Application No. 62/162,629, of the same titleand filed on May 15, 2015, for priority, both of which are hereinincorporated by reference in their entirety.

FIELD

The present specification relates to apparatuses, systems, and methodsfor cleaning, disinfecting or sterilizing medical instruments anddevices. More particularly, the present specification relates to systemsand methods for sterilizing medical devices, such as catheters andendoscopes, using superheated steam, or any other suitable sterilizingagent.

BACKGROUND

According to the Centers for Disease Control and Prevention,approximately 46.5 million surgical procedures are performed each yearin the United States. Of those, approximately 5 million comprisegastrointestinal endoscopies, considered a more invasive medicalprocedure. Following these endoscopies, disinfection and sterilizationare essential for ensuring that the medical and surgical instruments donot transmit infectious pathogens to subsequent patients.

Cleaning is described as the removal of visible soil (e.g., organic andinorganic material) from objects and surfaces and normally isaccomplished manually or mechanically using water with detergents orenzymatic products. Thorough cleaning is essential before high-leveldisinfection and sterilization because inorganic and organic materialsthat remain on the surfaces of instruments interfere with theeffectiveness of these processes. Also, if soiled materials dry or bakeonto the instruments, the removal process becomes more difficult and thedisinfection or sterilization process less effective or ineffective.Surgical instruments are typically presoaked or rinsed to prevent dryingof blood and to soften or remove blood from the instruments.

Cleaning is done manually in use areas without mechanical units (e.g.,ultrasonic cleaners or washer-disinfectors) or for fragile ordifficult-to-clean instruments. With manual cleaning, the two essentialcomponents are friction and fluidics. Friction is accomplished, forexample, by rubbing/scrubbing the soiled area with a brush. Fluidics(i.e., fluids under pressure) is used to remove soil and debris frominternal channels after brushing and when the design does not allowpassage of a brush through a channel. When a washer-disinfector is used,care is taken in loading instruments. For example, hinged instrumentsare opened fully to allow adequate contact with the detergent solution,stacking of instruments in washers is avoided, and instruments aredisassembled as much as possible.

The most common types of mechanical or automatic cleaners are ultrasoniccleaners, washer-decontaminators, washer-disinfectors, andwasher-sterilizers. Ultrasonic cleaning removes soil by cavitation andimplosion in which waves of acoustic energy are propagated in aqueoussolutions to disrupt the bonds that hold particulate matter to surfaces.

Disinfection describes a process that eliminates many or all pathogenicmicroorganisms, except bacterial spores, on inanimate objects.Disinfection is usually performed using liquid chemicals or wetpasteurization. High-level disinfection traditionally is defined ascomplete elimination of all microorganisms in or on an instrument,except for small numbers of bacterial spores. The Food and DrugAdministration (FDA) definition of high-level disinfection is asterilant used for a shorter contact time to achieve a 6-log 10 kill ofan appropriate Mycobacterium species. Cleaning followed by high-leveldisinfection should eliminate enough pathogens to prevent transmissionof infection.

Laparoscopes and arthroscopes in the United States sometimes undergoonly high-level disinfection between patients. As with flexibleendoscopes, these devices can be difficult to clean and high-leveldisinfect or sterilize because of intricate device design (e.g., longnarrow lumens, hinges). Meticulous cleaning must precede any high-leveldisinfection or sterilization process.

Sterilization describes a process that destroys or eliminates all formsof microbial life and is carried out in health-care facilities byphysical or chemical methods. Steam under pressure, dry heat, ethyleneoxide (EtO) gas, hydrogen peroxide gas plasma, and liquid chemicals arethe principal sterilizing agents used in health-care facilities.

Factors that affect the efficacy of both disinfection and sterilizationinclude prior cleaning of the object, organic and inorganic loadpresent, type and level of microbial contamination, concentration of andexposure time to the germicide, physical nature of the object (e.g.,crevices, hinges, and lumens), presence of biofilms, temperature and pHof the disinfection process, and in some cases, relative humidity of thesterilization process.

Decontamination removes pathogenic microorganisms from objects so theyare safe to handle, use, or discard.

Rinsing endoscopes and flushing endoscope channels with sterile water,filtered water, or tap water will prevent adverse effects associatedwith disinfectant retained in the endoscope (e.g., disinfectant-inducedcolitis). Items can be rinsed and flushed using sterile water afterhigh-level disinfection to prevent contamination with organisms in tapwater, such as nontuberculous mycobacteria, Legionella, or gram-negativebacilli such as Pseudomonas. Alternatively, a tap water or filteredwater (0.2 m filter) rinse should be followed by an alcohol rinse andforced air drying. Forced-air drying markedly reduces bacterialcontamination of stored endoscopes, most likely by removing the wetenvironment favorable for bacterial growth. After rinsing, items shouldbe dried and stored (e.g., packaged) in a manner that protects them fromrecontamination.

Physicians use endoscopes to diagnose and treat numerous medicaldisorders. Even though endoscopes represent a valuable diagnostic andtherapeutic tool in modern medicine and the incidence of infectionassociated with their use reportedly is very low (about 1 in 1.8 millionprocedures), more healthcare-associated outbreaks have been linked tocontaminated endoscopes than to any other medical device. To prevent thespread of health-care-associated infections, all heat-sensitiveendoscopes (e.g., gastrointestinal endoscopes, bronchoscopes,nasopharyngoscopes) must be properly cleaned and, at a minimum,subjected to high-level disinfection after each use. High-leveldisinfection can be expected to destroy all microorganisms, althoughwhen high numbers of bacterial spores are present, a few spores mightsurvive.

Because of the types of body cavities they enter, flexible endoscopesacquire high levels of microbial contamination (bioburden) during eachuse. For example, the bioburden found on flexible gastrointestinalendoscopes after use has ranged from 10⁵ colony forming units (CFU)/mLto 10¹⁰ CFU/mL, with the highest levels found in the suction channels.The average load on bronchoscopes before cleaning was 6.4×10⁴ CFU/ml.Cleaning reduces the level of microbial contamination by 4-6 log₁₀.Using human immunovirus (HIV)-contaminated endoscopes, severalinvestigators have shown that cleaning completely eliminates themicrobial contamination on the scopes. Similarly, other investigatorsfound that EtO sterilization or soaking in 2% glutaraldehyde for 20minutes was effective only when the device first was properly cleaned.

The FDA maintains a list of cleared liquid chemical sterilants andhigh-level disinfectants that can be used to reprocess heat-sensitivemedical devices, such as flexible endoscopes. At this time, theFDA-cleared and marketed formulations include: ≥2.4% glutaraldehyde,0.55% ortho-phthalaldehyde (OPA), 0.95% glutaraldehyde with 1.64%phenol/phenate, 7.35% hydrogen peroxide with 0.23% peracetic acid, 1.0%hydrogen peroxide with 0.08% peracetic acid, and 7.5% hydrogen peroxide.These products have excellent antimicrobial activity; however, someoxidizing chemicals (e.g., 7.5% hydrogen peroxide and 1.0% hydrogenperoxide with 0.08% peracetic acid) reportedly have caused cosmetic andfunctional damage to endoscopes. EtO sterilization of flexibleendoscopes is infrequent because it requires a lengthy processing andaeration time (e.g., 12 hours) and is a potential hazard to staff andpatients. The two products most commonly used for reprocessingendoscopes in the United States are glutaraldehyde and an automated,liquid chemical sterilization process that uses peracetic acid. TheAmerican Society for Gastrointestinal Endoscopy (ASGE) recommendsglutaraldehyde solutions that do not contain surfactants because thesoapy residues of surfactants are difficult to remove during rinsing.Ortho-phthalaldehyde has begun to replace glutaraldehyde in manyhealth-care facilities because it has several potential advantages overglutaraldehyde. Ortho-phthalaldehyde is not known to irritate the eyesand nasal passages, does not require activation or exposure monitoring,and has a 12-minute high-level disinfection claim in the United States.Disinfectants that are not FDA-cleared and should not be used forreprocessing endoscopes include iodophors, chlorine solutions, alcohols,quaternary ammonium compounds, and phenolics. These solutions mightstill be in use outside the United States, but their use is discouragedbecause of lack of proven efficacy against all microorganisms ormaterials incompatibility.

Flexible endoscopes are particularly difficult to disinfect and easy todamage because of their intricate design and delicate materials.Meticulous cleaning must precede any sterilization or high-leveldisinfection of these instruments. Failure to perform good cleaning canresult in sterilization or disinfection failure and outbreaks ofinfection can occur. Several studies have demonstrated the importance ofcleaning in experimental studies with the duck hepatitis B virus (HBV),HIV, and Helicobacter pylori.

An examination of health-care-associated infections related only toendoscopes through July 1992 found 281 infections transmitted bygastrointestinal endoscopy and 96 transmitted by bronchoscopy. Theclinical spectrum ranged from asymptomatic colonization to death.Salmonella species and Pseudomonas aeruginosa repeatedly were identifiedas causative agents of infections transmitted by gastrointestinalendoscopy, and M. tuberculosis, atypical mycobacteria, and P. aeruginosawere the most common causes of infections transmitted by bronchoscopy.Major reasons for transmission were inadequate cleaning, improperselection of a disinfecting agent, failure to follow recommendedcleaning and disinfection procedures, and flaws in endoscope design orautomated endoscope reprocessors. Failure to follow establishedguidelines has continued to result in infections associated withgastrointestinal endoscopes and bronchoscopes. One multistateinvestigation found that 23.9% of the bacterial cultures from theinternal channels of 71 gastrointestinal endoscopes grew >100,000colonies of bacteria after completion of all disinfection andsterilization procedures and before use on the next patient.

Automated endoscope reprocessors (AER) offer several advantages overmanual reprocessing. AERs automate and standardize several importantreprocessing steps, reduce the likelihood that an essential reprocessingstep will be skipped, and reduce personnel exposure to high-leveldisinfectants or chemical sterilants. Failure of AERs has been linked tooutbreaks of infections or colonization, and the AER water filtrationsystem might not be able to reliably provide “sterile” or bacteria-freerinse water. Establishment of correct connectors between the AER and thedevice is critical to ensure complete flow of disinfectants and rinsewater. In addition, some endoscopes, such as the duodenoscopes (e.g.,for endoscopic retrograde cholangiopancreatography [ERCP]), containfeatures (e.g., elevator-wire channel) that require a flushing pressurethat is not achieved by most AERs and must be reprocessed manually usinga 2- to 5-mL syringe, until new duodenoscopes equipped with a widerelevator-channel that AERs can reliably reprocess become available.Outbreaks involving removable endoscope parts, such as suction valvesand endoscopic accessories designed to be inserted through flexibleendoscopes, such as biopsy forceps, emphasize the importance of cleaningto remove all foreign matter before high-level disinfection orsterilization. Some types of valves are now available as single-use,disposable products (e.g., bronchoscope valves) or steam sterilizableproducts (e.g., gastrointestinal endoscope valves).

AERs need further development and redesign, as do endoscopes, so thatthey do not represent a potential source of infectious agents.Endoscopes employing disposable components (e.g., protective barrierdevices or sheaths) might provide an alternative to conventional liquidchemical high-level disinfection/sterilization. Another new technologyis a swallowable camera-in-a-capsule that travels through the digestivetract and transmits color pictures of the small intestine to a receiverworn outside the body. This capsule currently does not replacecolonoscopies.

In general, endoscope disinfection or sterilization with a liquidchemical sterilant involves five steps after leak testing:

-   -   1. Clean: mechanically clean internal and external surfaces,        including brushing internal channels and flushing each internal        channel with water and a detergent or enzymatic cleaners (leak        testing is recommended for endoscopes before immersion).    -   2. Disinfect: immerse endoscope in high-level disinfectant (or        chemical sterilant) and perfuse (eliminates air pockets and        ensures contact of the germicide with the internal channels)        disinfectant into all accessible channels, such as the        suction/biopsy channel and air/water channel and expose for a        time recommended for specific products.    -   3. Rinse: rinse the endoscope and all channels with sterile        water, filtered water (commonly used with AERs) or tap water        (i.e., high-quality potable water that meets federal clean water        standards at the point of use).    -   4. Dry: rinse the insertion tube and inner channels with        alcohol, and dry with forced air after disinfection and before        storage.    -   5. Store: store the endoscope in a way that prevents        recontamination and promotes drying.

Methicillin-resistant Staphylococcus aureus (MRSA) andvancomycin-resistant Enterococcus (VRE) are importanthealth-care-associated agents. Some antiseptics and disinfectants havebeen known to be somewhat less inhibitory to Staphylococcus aureusstrains that contain a plasmid-carrying gene encoding resistance to theantibiotic gentamicin. For example, gentamicin resistance has been shownto also encode reduced susceptibility to propamidine, quaternaryammonium compounds, and ethidium bromide, and MRSA strains have beenfound to be less susceptible than methicillin-sensitive Staphylococcusaureus (MSSA) strains to chlorhexidine, propamidine, and the quaternaryammonium compound cetrimide. In other studies, MRSA and MSSA strainshave been equally sensitive to phenols and chlorhexidine, but MRSAstrains were slightly more tolerant to quaternary ammonium compounds.Two gene families (qacCD [now referred to as smr] and qacAB) areinvolved in providing protection against agents that are components ofdisinfectant formulations such as quaternary ammonium compounds.Staphylococci have been proposed to evade destruction because theprotein specified by the qacA determinant is acytoplasmic-membrane-associated protein involved in an efflux systemthat actively reduces intracellular accumulation of toxicants, such asquaternary ammonium compounds, to intracellular targets.

A study that evaluated the efficacy of selected cleaning methods (e.g.,quaternary ammonium cation [QUAT]-sprayed cloth, and QUAT-immersedcloth) for eliminating VRE found that currently used disinfectionprocesses most likely are highly effective in eliminating VRE. However,surface disinfection must involve contact with all contaminatedsurfaces.

Organic matter in the form of serum, blood, pus, fecal, or lubricantmaterial can interfere with the antimicrobial activity of disinfectantsin at least two ways. Most commonly, interference occurs by a chemicalreaction between the germicide and the organic matter resulting in acomplex that is less germicidal or nongermicidal, leaving less of theactive germicide available for attacking microorganisms. Chlorine andiodine disinfectants, in particular, are prone to such interaction.Alternatively, organic material can protect microorganisms from attackby acting as a physical barrier.

All lumens and channels of endoscopic instruments must contact thedisinfectant. Air pockets interfere with the disinfection process, anditems that float on the disinfectant will not be disinfected. Thedisinfectant must be introduced reliably into the internal channels ofthe device. The exact times for disinfecting medical items are somewhatelusive because of the effect of the aforementioned factors ondisinfection efficacy. Certain contact times have proved reliable, but,in general, longer contact times are more effective than shorter contacttimes.

Microorganisms may be protected from disinfectants by the production ofthick masses of cells and extracellular materials, or biofilms.

Of all the methods available for sterilization, moist heat in the formof saturated steam under pressure is the most widely used and the mostdependable. Steam sterilization is nontoxic, inexpensive, rapidlymicrobicidal, sporicidal, and rapidly heats and penetrates fabrics. Likeall sterilization processes, steam sterilization has some deleteriouseffects on some materials, including corrosion and combustion oflubricants associated with dental handpieces, reduction in ability totransmit light associated with laryngoscopes, and increased hardeningtime (5.6 fold) with plaster-cast.

The basic principle of steam sterilization, as accomplished in anautoclave, is to expose each item to direct steam contact at therequired temperature and pressure for the specified time. Thus, thereare four parameters of steam sterilization: steam, pressure,temperature, and time. The ideal steam for sterilization is drysaturated steam and entrained water (dryness fraction ≥97%). Pressureserves as a means to obtain the high temperatures necessary to quicklykill microorganisms. Specific temperatures must be obtained to ensurethe microbicidal activity. The two common steam-sterilizing temperaturesare 121° C. (250° F.) and 132° C. (270° F.). These temperatures (andother high temperatures) must be maintained for a minimal time to killmicroorganisms. Recognized minimum exposure periods for sterilization ofwrapped healthcare supplies are 30 minutes at 121° C. (250° F.) in agravity displacement sterilizer or 4 minutes at 132° C. (270° C.) in aprevacuum sterilizer. At constant temperatures, sterilization times varydepending on the type of item (e.g., metal versus rubber, plastic, itemswith lumens), whether the item is wrapped or unwrapped, and thesterilizer type.

The two basic types of steam sterilizers (autoclaves) are the gravitydisplacement autoclave and the high-speed prevacuum sterilizer.

Another design in steam sterilization is a steam flush-pressure pulsingprocess, which removes air rapidly by repeatedly alternating a steamflush and a pressure pulse above atmospheric pressure. Air is rapidlyremoved from the load as with the prevacuum sterilizer, but air leaks donot affect this process because the steam in the sterilizing chamber isalways above atmospheric pressure. Typical sterilization temperaturesand times are 132° C. to 135° C. with 3 to 4 minutes exposure time forporous loads and instruments.

Moist heat destroys microorganisms by the irreversible coagulation anddenaturation of enzymes and structural proteins. In support of thisfact, it has been found that the presence of moisture significantlyaffects the coagulation temperature of proteins and the temperature atwhich microorganisms are destroyed.

Steam sterilization should be used whenever possible on all critical andsemicritical items that are heat and moisture resistant (e.g., steamsterilizable respiratory therapy and anesthesia equipment), even whennot essential to prevent pathogen transmission. Steam sterilizers alsoare used in healthcare facilities to decontaminate microbiological wasteand sharps containers but additional exposure time is required in thegravity displacement sterilizer for these items.

“Flash” steam sterilization was originally defined by Underwood andPerkins as sterilization of an unwrapped object at 132° C. for 3 minutesat 27-28 lbs. of pressure in a gravity displacement sterilizer.

Hydrogen peroxide is another agent used in disinfection andsterilization. Published reports ascribe good germicidal activity tohydrogen peroxide and attest to its bactericidal, virucidal, sporicidal,and fungicidal properties. Hydrogen peroxide works by producingdestructive hydroxyl free radicals that can attack membrane lipids, DNA,and other essential cell components. Catalase, produced by aerobicorganisms and facultative anaerobes that possess cytochrome systems, canprotect cells from metabolically produced hydrogen peroxide by degradinghydrogen peroxide to water and oxygen. This defense is overwhelmed bythe concentrations used for disinfection. Concentrations of hydrogenperoxide from 6% to 25% show promise as chemical sterilants. The productmarketed as a sterilant is a premixed, ready-to-use chemical thatcontains 7.5% hydrogen peroxide and 0.85% phosphoric acid (to maintain alow pH). When the effectiveness of 7.5% hydrogen peroxide at 10 minuteswas compared with 2% alkaline glutaraldehyde at 20 minutes in manualdisinfection of endoscopes, no significant difference in germicidalactivity was observed. A new, rapid-acting 13.4% hydrogen peroxideformulation (that is not yet FDA-cleared) has demonstrated sporicidal,mycobactericidal, fungicidal, and virucidal efficacy. Manufacturer datademonstrate that this solution sterilizes in 30 minutes and provideshigh-level disinfection in 5 minutes.

SUMMARY

The present specification discloses a method of disinfecting orsterilizing an endoscope where the endoscope has an external surface anda lumen, said method comprising the steps of: attaching a pressureresistance fitting to the scope tip or one of the openings of the lumen;and delivering super-heated steam through the pressure fitting.

Optionally, the method further includes the step of attaching a suctionmechanism to one of the other openings of the lumen and suctioning thesuper-heated steam.

The delivery of superheated steam and the rate of suction may becontrolled by a microprocessor.

Optionally, at least one temperature or pressure sensor is housed in apath of the superheated steam wherein said method further comprises thestep of using data from said at least one sensor to control the rate offlow of superheated steam or the rate of suction.

Optionally, said microprocessor includes a user interface to input datafrom an operator and provide progress information back to the operator.

The present specification also discloses an apparatus for disinfectingor sterilizing an endoscope, comprising: at least one pressure resistantcompression fitting designed to be operably attached to one opening ofan endoscope; a steam generator capable of generating super-heated steamand attached to said at least one pressure resistant compression fittingvia a length of tubing; at least one pressure resistant vacuum suctionfitting designed to be operably attached to another opening of anendoscope at one end and attached to a vacuum suction at the other end;and a microprocessor operably attached to the steam generator and vacuumpump to control the rate of delivery of steam and rate of suction.

Optionally, the apparatus further comprises additional steam deliveryports for delivery of steam into one of the other openings of theendoscope.

Optionally, the apparatus further comprises additional suction ports forsuction of steam from one of the other openings of the endoscope.

Optionally, the apparatus further comprises sensors to measure at leastone of a plurality of parameters of the steam and input measured datainto the microprocessor to control the delivery of steam or rate ofsuction or both.

Optionally, the microprocessor further comprises a user interface toinput operational data or to monitor the progress of disinfection orsterilization.

The present specification also discloses a method of disinfecting orsterilizing an endoscope where the endoscope has an external surface anda lumen, said method comprising the steps of: placing the endoscope in athermally insulating casing designed to house the endoscope; attaching apressure resistance fitting to the scope tip or one of the openings ofthe lumen; delivering super-heated steam through the pressure fitting tofill the endoscope channels; and allowing the steam to escape from oneof the other openings in the endoscope and into a space between theendoscope and the casing.

Optionally, the method further comprises the steps of attaching asuction mechanism to the casing and suctioning the super-heated steamfrom around the endoscope to maintain the desired pressure andtemperature.

The delivery of superheated steam and the rate of suction may becontrolled by a microprocessor.

Optionally, at least one temperature or pressure sensor is housed in apath of the superheated steam and said method further comprises the stepof using data from said at least one sensor to control the rate of flowof superheated steam or the rate of suction.

Optionally, said microprocessor includes a user interface to input datafrom an operator and provide progress information back to the operator.

The present specification also discloses an apparatus for disinfectingor sterilizing an endoscope, comprising: a thermally insulating casingwith at least one pressure resistant compression fitting designed to beoperably attached to one opening of an endoscope; a steam generatorcapable of generating and delivering super-heated steam and attached tosaid pressure resistant compressing fitting; at least one vacuum suctionport operably attached to the casing at one end and attached to a vacuumsuction at the other end to provide suction; and a microprocessoroperably attached to the steam generator and vacuum pump to control therate of delivery of steam and rate of suction.

Optionally, the apparatus further comprises additional steam deliveryports for delivery of steam into one of the other openings of theendoscope.

Optionally, the apparatus further comprises additional suction ports forthe suction of steam from one of the other openings of the endoscope.

Optionally, the apparatus further comprises at least one sensor tomeasure any one of a plurality of parameters of the steam and inputmeasured data into the microprocessor to control the delivery of steamor rate of suction or both.

Optionally, said microprocessor includes a user interface to inputoperational data or to monitor the progress of disinfection orsterilization.

The present specification also discloses an apparatus for disinfectingor sterilizing an endoscope, comprising: at least two chambers separatedby a removable separating component; a space for placing an endoscopewherein a first portion of said endoscope comprising at least one firstendoscope port is positioned in a first chamber of said at least twochambers and a second portion of said endoscope comprising at least onesecond endoscope port is positioned in a second chamber of said at leasttwo chambers; at least one first opening providing fluid communicationbetween said first chamber and an outside area of said apparatus; and atleast one second opening providing fluid communication between saidsecond chamber and an outside area of said apparatus; wherein adisinfecting or sterilizing agent is introduced under pressure throughsaid first or second opening and into said first or second chamber andwherein a pressure difference between said first chamber and said secondchamber causes said disinfecting or sterilizing agent to enter saidendoscope through said first endoscope port or said second endoscopeport, pass through one or more endoscope channels of said endoscope,exit said endoscope through said first endoscope port or said secondendoscope port not comprising the endoscope port through which saiddisinfecting or sterilizing agent entered said endoscope, and exit saidapparatus through said first or second opening not comprising theopening through which the disinfecting or sterilizing agent entered saidapparatus.

The aforementioned and other embodiments of the present invention shallbe described in greater depth in the drawings and detailed descriptionprovided below.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present invention will befurther appreciated, as they become better understood by reference tothe detailed description when considered in connection with theaccompanying drawings, wherein:

FIG. 1A is an illustration of an endoscope, depicting a plurality ofports;

FIG. 1B is an illustration of an endoscope handle, depicting a pluralityof ports;

FIG. 1C is another illustration of an endoscope handle, depicting aplurality of ports;

FIG. 1D is a block diagram of an endoscope, depicting a plurality ofports;

FIG. 2 is a close-up illustration of a plurality of ports on anendoscope;

FIG. 3 is a close-up illustration of a connector of an endoscopedepicting a plurality of ports;

FIG. 4A is a cross-sectional illustration of an endoscope, depicting asuction channel extending through the endoscope body;

FIG. 4B is a cross-sectional illustration of an endoscope, depicting aplurality of channels extending through the endoscope body;

FIG. 5A is an illustration of an endoscope depicting an embodiment ofpressure resistant fittings for covering a plurality of ports on theendoscope;

FIG. 5B is an illustration of compression fittings in accordance withone embodiment of the present specification;

FIG. 6A is an illustration of a system for sterilizing an endoscopeusing steam, in accordance with one embodiment of the presentspecification;

FIG. 6B is another illustration of a system for sterilizing an endoscopeusing steam, in accordance with another embodiment of the presentspecification;

FIG. 6C is an illustration of a system for sterilizing an endoscopeusing steam, in accordance with another embodiment of the presentspecification;

FIG. 6D is an illustration of a system for sterilizing an endoscopeusing steam, in accordance with another embodiment of the presentspecification;

FIG. 6E is an illustration of a system for sterilizing an endoscopeusing steam, in accordance with another embodiment of the presentspecification;

FIG. 6F is an illustration of a system for sterilizing an endoscopeusing steam, in accordance with another embodiment of the presentspecification;

FIG. 6G is an illustration of a system for sterilizing an endoscopeusing steam, in accordance with another embodiment of the presentspecification;

FIG. 6H is an illustration of a system for sterilizing an endoscopeusing steam, in accordance with another embodiment of the presentspecification;

FIG. 6I is an illustration of a system for sterilizing an endoscopeusing steam, in accordance with another embodiment of the presentspecification;

FIG. 6J is an illustration of a system for sterilizing an endoscopeusing steam, in accordance with yet another embodiment of the presentspecification;

FIG. 7A is an illustration of a compression fitting to connect a steamgenerator to an endoscope for sterilization, in accordance with oneembodiment of the present specification;

FIG. 7B is an illustration of a plurality of compression fittings toconnect a steam generator to an endoscope for sterilization, inaccordance with various embodiments of the present specification;

FIG. 7C is an illustration of a plurality of compression fittings usedto connect a steam generator to an endoscope for sterilization, inaccordance with other embodiments of the present specification;

FIG. 7D is an illustration of a compression fitting connected to anendoscope for sterilization, in accordance with various embodiments ofthe present specification;

FIG. 7E is an illustration of a plurality of compression fittingsconnecting a steam generator to an endoscope for sterilization, inaccordance with various embodiments of the present specification;

FIG. 7F is an illustration of compression fittings connected to anendoscope for sterilization, in accordance with an embodiment of thepresent specification;

FIG. 7G is an illustration of a compression fitting connected to anendoscope for sterilization, in accordance with another embodiment ofthe present specification;

FIG. 8A is a flowchart listing the steps involved in a method of usingsteam to sterilize an endoscope, in accordance with one embodiment ofthe present specification;

FIG. 8B is a flowchart listing the steps involved in a method of usingsteam to sterilize an endoscope, in accordance with another embodimentof the present specification;

FIG. 9A is an illustration of a pressure resistant fitting including anexpandable membrane, in accordance with one embodiment of the presentspecification;

FIG. 9B is an illustration of a pressure resistant fitting including anexpandable membrane, in accordance with another embodiment of thepresent specification;

FIG. 10A is a flowchart listing the steps involved in a method of usingsteam to sterilize an endoscope, in accordance with another embodimentof the present specification;

FIG. 10B is a flowchart listing the steps involved in a method of usingsteam to sterilize an endoscope, in accordance with yet anotherembodiment of the present specification;

FIG. 11A is a cross-sectional illustration of an endoscope depicting thepathway of steam during a sterilization procedure, in accordance withone embodiment of the present specification;

FIG. 11B is a cross-sectional illustration of an endoscope depicting thepathway of steam during a sterilization procedure, in accordance withanother embodiment of the present specification;

FIG. 11C is a cross-sectional illustration of an endoscope depicting thepathway of steam during a sterilization procedure, in accordance withyet another embodiment of the present specification;

FIG. 12 is a graph illustrating the relationship between time, pressure,and temperature for various stages of sterilizing an endoscope usingsteam, in accordance with some embodiments of the present specification;

FIG. 13A is an illustration of a distal end of an endoscope used in ERCPprocedures, depicting an elevator channel;

FIG. 13B is an illustration of movement of an elevator at the distal tipof an endoscope to allow for complete sterilization, in accordance withone embodiment of the present specification;

FIG. 14A is an illustration of a thermally insulated casing for use withsteam sterilization of an endoscope, in accordance with one embodimentof the present specification;

FIG. 14B is an illustration of a thermally insulated casing for use withsteam sterilization of an endoscope, in accordance with anotherembodiment of the present specification;

FIG. 14C is an illustration of a thermally insulated casing for use withsteam sterilization of an endoscope, in accordance with yet anotherembodiment of the present specification;

FIG. 15 is a flowchart listing the steps involved in a method of using athermally insulated casing and steam to sterilize an endoscope, inaccordance with one embodiment of the present specification;

FIG. 16 is an illustration of an endoscope capable of withstanding hightemperatures involved with steam sterilization, in accordance with oneembodiment of the present specification;

FIG. 17A is an illustration of a thermally insulated casing orsterilization chamber subdivided into one or more chambers, inaccordance with one embodiment of the present specification;

FIG. 17B is an illustration of a thermally insulated casing orsterilization chamber subdivided into one or more chambers, inaccordance with another embodiment of the present specification; and

FIG. 18 is a flowchart illustrating the steps of sterilizing anendoscope by using pressurized chambers, in accordance with anembodiment of the present specification.

DETAILED DESCRIPTION

The present specification discloses apparatuses and methods forreprocessing, disinfecting, or sterilizing medical equipment, such asendoscopes, using steam or other sterilizing or disinfecting agentsknown in the art. The devices are sterilized by attaching a mechanismhaving a pressure resistant, compression fitting to the tip of anendoscope wherein the mechanism is configured to deliver superheated(SH) steam or another sterilizing agent. Additional pressure resistantfittings are attached to the openings in the various channels of theendoscope and a vacuum pump is attached to each channel, thus creating aclosed system for the circulation of the sterilizing or disinfectingagent. Optional pressure and temperature sensors are disposed in variousfittings to monitor the pressure and the temperature of the closedsystem. Optional pressure regulated valves are disposed in variousfittings to open when a certain pressure is reached.

“Treat,” “treatment,” and variations thereof refer to any reduction inthe extent, frequency, or severity of one or more symptoms or signsassociated with a condition.

“Duration” and variations thereof refer to the time course of aprescribed treatment, from initiation to conclusion, whether thetreatment is concluded because the condition is resolved or thetreatment is suspended for any reason. Over the duration of treatment, aplurality of treatment periods may be prescribed during which one ormore prescribed stimuli are administered to the subject.

“Period” refers to the time over which a “dose” of stimulation isadministered to a subject as part of the prescribed treatment plan.

The term “and/or” means one or all of the listed elements or acombination of any two or more of the listed elements.

The terms “comprises” and variations thereof do not have a limitingmeaning where these terms appear in the description and claims.

Unless otherwise specified, “a,” “an,” “the,” “one or more,” and “atleast one” are used interchangeably and mean one or more than one.

For any method disclosed herein that includes discrete steps, the stepsmay be conducted in any feasible order. And, as appropriate, anycombination of two or more steps may be conducted simultaneously.

Also herein, the recitations of numerical ranges by endpoints includeall numbers subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2,2.75, 3, 3.80, 4, 5, etc.). Unless otherwise indicated, all numbersexpressing quantities of components, molecular weights, and so forthused in the specification and claims are to be understood as beingmodified in all instances by the term “about.” Accordingly, unlessotherwise indicated to the contrary, the numerical parameters set forthin the specification and claims are approximations that may varydepending upon the desired properties sought to be obtained by thepresent specification. At the very least, and not as an attempt to limitthe doctrine of equivalents to the scope of the claims, each numericalparameter should at least be construed in light of the number ofreported significant digits and by applying ordinary roundingtechniques.

Notwithstanding that the numerical ranges and parameters setting forththe broad scope of the specification are approximations, the numericalvalues set forth in the specific examples are reported as precisely aspossible. All numerical values, however, inherently contain a rangenecessarily resulting from the standard deviation found in theirrespective testing measurements.

The present invention is directed towards multiple embodiments. Thefollowing disclosure is provided in order to enable a person havingordinary skill in the art to practice the invention. Language used inthis specification should not be interpreted as a general disavowal ofany one specific embodiment or used to limit the claims beyond themeaning of the terms used therein. The general principles defined hereinmay be applied to other embodiments and applications without departingfrom the spirit and scope of the invention. Also, the terminology andphraseology used is for the purpose of describing exemplary embodimentsand should not be considered limiting. Thus, the present invention is tobe accorded the widest scope encompassing numerous alternatives,modifications and equivalents consistent with the principles andfeatures disclosed. For purpose of clarity, details relating totechnical material that is known in the technical fields related to theinvention have not been described in detail so as not to unnecessarilyobscure the present invention.

It should be noted herein that any feature or component described inassociation with a specific embodiment may be used and implemented withany other embodiment unless clearly indicated otherwise.

In one embodiment, an apparatus for reprocessing, disinfecting, orsterilizing medical equipment, such as endoscopes, comprises amechanism, such as a steam generator, having a pressure resistant,compression fitting which is attached to the tip of an endoscope andconfigured to deliver superheated (SH) steam or hydrogen peroxide oranother sterilizing agent. Tubing connects the compression fitting to asteam generator. Additional pressure resistant fittings are attached tothe openings in the various channels of the endoscope. An attachment toa vacuum pump is included per channel, thus creating a closed system forthe circulation of steam or a sterilizing agent. In some embodiments,optional pressure and temperature sensors are disposed in variousfittings to monitor the pressure and the temperature of the closedsystem. In some embodiments, optional pressure regulated valves aredisposed in various fittings to open when a certain pressure is reached.

Super-heated (SH) steam at a desired temperature and pressure isdelivered through the compression fitting at the endoscope tip. Thesteam is pushed into various channels, pressurizing these channels. Inone embodiment, once the desired pressure is reached, pressure regulatedvalves open, allowing the steam to escape for circulation of the steamat the desired pressure and temperature through the channel. The SHsteam is circulated for a desired duration to achieve the desiredtherapeutic effect. In some embodiments, optional mechanisms to suctionaway the steam to prevent operator injury are disposed in the system.Optionally, in some embodiments, the whole system and the endoscope arehoused in a thermally insulating casing to prevent the escape of steamand injury to the operator. In some embodiments, the casing furtherhouses optional temperature and pressure sensors to monitor the progressof sterilization. In some embodiments, optional temperature and pressuresensors are disposed in various fittings to monitor the sterilizationprocess. In various embodiments, the delivery of SH steam is controlledby a microprocessor and modified by input from various sensors. In someembodiments, the microprocessor has a user interface for users to inputvarious parameters for adequate sterilization.

In one embodiment, the operator can manipulate the elevator controllever to move the elevator of a duodenoscope, allowing for SH steam toenter various crevices around the elevator. In another embodiment, amechanical mechanism is used to manipulate the elevator lever while thesteam is being circulated.

In another embodiment the sterilizing agent is hydrogen peroxide orionized plasma gas. In some embodiments the sterilization process can becombined with other sterilizing agents such as UV radiation or ethyleneoxide sterilization or other sterilization agents known in the field.

In another embodiment, the pressure resistant fittings attached to thevarious channel openings are attached to a vacuum controlled by amicroprocessor. As the delivery of SH steam starts, the vacuum startssuctioning the air in the various channels, allowing for steam to flowthroughout the channel. As the temperature of the suctioned airapproaches 100° C., the vacuum shuts down, creating a closed systemwhile the SH steam is continually being delivered. Both the temperatureand the pressure in the scope channels rise and, when the desiredtemperature or pressure value is reached, the vacuum restarts,circulating the superheated steam through the endoscope channels. Thedelivery of SH steam and the rate of vacuum are matched by themicroprocessor to maintain a steady state temperature and pressure for adesired duration, following which the delivery of SH steam ceases andthe channels are deemed to be sterilized.

In various embodiments, the pressure in the system is continuallymonitored and a certain change in the pressure may signal a blockage ora leak modifying or shutting down the flow of SH steam.

In one embodiment, the sterilization system includes a thermallyinsulated casing and the vacuum mechanism is part of the casing. In thisembodiment, the SH steam is delivered at the tip through the compressionfitting and it pushes the air out of the channel into the space betweenthe endoscope and the casing. Pressure and temperature sensors aredisposed in the casing. As the temperature or pressure reaches apredetermined value, the vacuum starts suctioning, circulating the SHsteam in and around the endoscope. The delivery of SH steam and rate ofvacuum suctioned are matched to maintain a steady state temperature andpressure for a desired duration to achieve the desired level ofdisinfection or sterilization.

In another embodiment, the sterilization system includes a thermallyinsulated casing and the SH steam delivery mechanism is part of thecasing. In this embodiment, the SH steam is delivered from the casinginto the space around the endoscope. The vacuum suction tubing isattached to at least one opening of each channel. Pressure andtemperature sensors are disposed in the casing. At a predetermined timefrom the start of delivery of SH steam, the vacuum starts suctioning theair out of the channels, allowing for circulation of the SH steam inthrough the scope channel and around the endoscope. Alternatively, asthe temperature or pressure reaches a predetermined value, the vacuumstarts suctioning from the channel opening, thus circulating the SHsteam in and around the endoscope. The delivery of SH steam and rate ofvacuum suctioned are matched to maintain a steady state temperature andpressure for a desired duration to achieve the desired level ofdisinfection or sterilization. The input from various temperature andpressure sensors is used to determine the rate and flow of SH steam andthe rate of vacuum suction.

In another embodiment, the steam is forced through the channels of anendoscope through a compression fitting attached to the tip of theendoscope. Additional pressure resistant fittings are applied to theother openings of the channels in the endoscope. At least one fittingper channel has a pressure relief valve that opens at a pressure lowerthan the sterilization pressure. As the steam is pumped into the scopechannel, the pressure rises in the channel, opening one or more of therelief valves and allowing the steam to escape out of the scope channelinto the space around the endoscope, circulating the steam in and aroundthe endoscope. The steam is continually pumped until the desiredpressures and temperatures are reached and are maintained for thedesired duration to achieve the desired level of disinfection orsterilization.

In one embodiment, the pressure resistant compression fitting at the tipis an inflatable cuff that can be inflated and deflated to achieve thedesired level of circulation and disinfection or sterilization.

In various embodiments, additional sterilization or disinfection stepsor agents known in the art can be combined to achieve the desired levelof sterilization or disinfection. In various embodiments, the methods ofsterilization or disinfection of the present specification are combinedwith manual cleaning or other methods of sterilization or disinfection.In some embodiments, additional sterilization agents can be combinedwith SH steam to achieve the desired level of disinfection orsterilization.

In some embodiments, mechanical levers are housed in the casing tomechanically move any moving parts, such as an elevator control lever inan endoscope, allowing for SH steam to enter into crevices around thelever and also to dislodge any debris.

In various embodiments, a thermally insulating, water-tight fitting isprovided to cover and protect the electronic connectors of the endoscopefrom water or thermal damage.

In some embodiments, the present specification also discloses anendoscope which can withstand high-pressure, high-temperaturedisinfection. In one embodiment, the endoscope skin is made of athermally resistant material. In various embodiments, the thermallyresistant material is one of silicone, Teflon®, polyethyleneterephthalate (PET), polypropylene, polybenzimidazole, or athermoplastic polymer or any other material that can withstandtemperatures >100° C. and ideally >150° C.

In another embodiment, an additional insulation layer, comprising athermally resistant material, is positioned between the skin of theendoscope and the internal components of the endoscope to preventthermal damage to the endoscope components, such as the electronics.

FIG. 1A illustrates an endoscope comprising a plurality of ports.Endoscope 100 comprises a handle portion 102 coupled with a connectorportion 104 and an insertion tube 106, which is inserted into apatient's body cavity. The handle portion 102 comprises a plurality ofknobs and buttons 108 which are used to control and maneuver theinsertion tube 106 within the patient's body. The distal end of theinsertion tube 106 comprises a bending section 110 which may becontrolled via the handle 102. The bending section 110 ends in a tipportion comprising one or more cameras for capturing images/videos ofthe patient's internal organs. The connector 104 is used to connect theendoscope to a controller/computer (not shown in the figure) via aconnection port 112 which may be covered by a cover cap 114 when not inuse. The controller may be connected to one or more display screens fordisplaying the images/videos captured by the endoscope 100. Endoscope100 also comprises a plurality of ports such as ports 116, 118, 120 forinserting biopsy instruments into the patient's body cavity via theinsertion tube 106 and for delivery of air, water and providing suction.

FIG. 1B illustrates another view of an endoscope comprising a pluralityof ports. FIG. 1C illustrates yet another view of an endoscopecomprising a plurality of ports. Referring to FIGS. 1B and 1Csimultaneously, handle 102 comprises a suction port 130 and an air/waterport 132. A biopsy port 134 is provided for insertion of medicalinstruments into a patient's body cavity via the insertion tube of theendoscope.

FIG. 1D is a block diagram of an endoscope 100, depicting a plurality ofports or openings 107, 108, 109. Ports 107 may be used to deliver wateror air, ports 108 may be used for suction, and port 109 may be used forinserting biopsy tools. Each port 107, 108, 109 is in fluidcommunication with an opening at the distal tip 110 of the endoscope 100via channels within the endoscope 100.

FIG. 2 is a close-up illustration of a plurality of ports on anendoscope 202. FIG. 2 illustrates an auxiliary water port 205, a waterjet connector inlet port 210, and additional ports 208, 209. In anembodiment, each port may be closed off by means of a compressionfitting 215 described in subsequent sections of the presentspecification. FIG. 3 illustrates a connector 300 of an endoscopeshowing a plurality of ports 305.

FIG. 4A is a cross-sectional illustration of an endoscope 400, depictinga suction channel extending through the endoscope body. A handle 402 ofendoscope 400 comprises a suction cylinder 404 which is connected with afirst portion of a suction channel 406 extending to a distal tip 408 ofan insertion tube 410, and is used to provide suction when insertiontube 410 is inserted within a patient's body. The suction channel 406may also be used as a biopsy channel. The suction cylinder 404 is alsoconnected with a second portion of a suction channel 412 which extendsto a suction port 414 of a connector 416. During reprocessing, it isessential to sterilize the entire suction channel thoroughly. FIG. 4B isa cross-sectional illustration of an endoscope 400, depicting aplurality of channels 406, 407, 408, extending through the endoscopebody.

FIG. 5A is an illustration of an endoscope 500 and pressure resistantfittings 501, 509, 515 used for covering a plurality of ports on theendoscope 500, in accordance with an embodiment. The pressure resistantfittings 501 are intended to close the ports 505 provided on a handle507 of the endoscope 500. Similar pressure fittings 509 are used tocover/seal off port openings 511 provided on a connector portion 513during sterilization and reprocessing of the endoscope 500. Inembodiments, a pressure fitting 515 is also provided for sealing off theendoscope's tip 517. The pressure fittings resist the forces of thepressure of sterilization medium within the endoscope channels.

FIG. 5B is an illustration of compression fittings 502, 503 inaccordance with one embodiment of the present specification. In anembodiment, the compression fittings 502, 503 are pressure resistantconnectors which connect openings (such as ports 505, 511 and tip 517shown in FIG. 5A) on the endoscope to a steam generator and allow thepassage of super-heated steam through and into the endoscope channelsfor sterilization of the channels. In embodiments, any pressureresistant connections known in the field, such as but not limited toluer and spring loaded locking mechanisms, may be used as compressionfittings 502, 503. In some embodiments, the compression fittings 502,503 are able to withstand a pressure of at least 15 psi or 1 PSIG,desirably a pressure of at least 20 psi or 6 PSIG, and most desirably apressure of at least 30 psi or 15 PSIG.

FIG. 6A is an illustration of a system 620 for sterilizing an endoscopeusing steam, in accordance with one embodiment of the presentspecification. The system 620 comprises a steam generator 622 connectedto at least one compression fitting 623 by a length of tubing 624. Inembodiments, tubing 624 may be made of a heat resistant material, suchas but not limited to Teflon. In various embodiments, steam generator622 produces super-heated steam at a desired temperature ranging from120° C. to 135° C. and pressure ranging from 1 Psig to 50 psig. Steamgenerated by the steam generator 622 travels through the tubing 624 andthe compression fitting 623 and into the channels of an endoscope (notshown), pressurizing the channels. Pressure resistant fittings 625 coverthe remaining openings to create a closed system and, in someembodiments, are attached to the steam generator so they do not becomemisplaced. In embodiments, a shape of pressure resistant fittings 625may be modified according to a corresponding port of the endoscope beingfitted with it. Since, fittings 625 are pressure sensitive valves, inembodiments, once a desired pressure is reached within the endoscope'schannels, one or more of the fittings 625 open to release excesspressure by allowing the steam to escape, resulting in circulation ofthe steam at the desired pressure and temperature through the channels.

FIGS. 6B and 6C are illustrations of a system 620 for sterilizing anendoscope 600 using steam, in accordance with an embodiment of thepresent specification. FIG. 6B illustrates the sterilization system 620comprising a steam generator 622 connected to at least one compressionfitting 623 by a length of tubing 624. In the embodiment shown in FIGS.6B and 6C, the steam generator 622 is connected to the pressure fitting623 applied upon the opening/port provided in a tip of the endoscope600. Steam generated by the steam generator 622 travels through thetubing 624 and the compression fitting 623 into the channels 628 of theendoscope 600. Pressure resistant fittings 625 cover the remainingports/openings 626 to create a closed system.

FIGS. 6D, 6E and 6F illustrate close up views of the compression fittingshown in FIGS. 6B and 6C. Steam generator 622 delivers steam throughdelivery tubing 624 and compression fitting 623 into the channels 628 ofthe endoscope 600. The compression fitting 623 comprises a fitting body633 onto which a nut 634 is screwed into place to secure the compressionfitting 623 to a port of the endoscope 600. Fitting body 633 alsocomprises a compression ring 654 which get compressed as the nut 634 istightened creating a seal. In an embodiment, the fitting body 633 isshaped like a cap to fit on the port. The compression fitting 623 isshaped such that it has a flat portion and a ramp portion 654. Referringto FIG. 6E, the compression fitting 623 comprises a flat O-ringconnected to a ramp 655 which is in turn connected to an O-ring 656 toprovide a better seal. Referring to FIG. 6F, the compression fitting 623comprises a ramp 657 connected to O ring 627.

FIGS. 6G and 6H are illustrations of a system 620 for sterilizing anendoscope 600 using steam, in accordance with another embodiment of thepresent specification. FIGS. 6G and 6H illustrate the sterilizationsystem 620 comprising a steam generator 622 connected to at least onecompression fitting 623 by a length of tubing 624. In the embodimentshown in FIG. 6G the steam generator 622 is simultaneously connected totwo pressure fittings 623 applied upon the two openings/ports providedon a connector of the endoscope 600. In the embodiment shown in FIG. 6Hthe steam generator 622 is connected to a pressure fitting 623 appliedupon one of the openings/ports provided on a connector 634 of theendoscope 600. Steam generated by the steam generator 622 travelsthrough the tubing 624 and the compression fitting 623 into the channels628 of the endoscope 600. Pressure resistant fittings 625 cover theremaining ports/openings such as ports 626 in a handle 632 of theendoscope and the opening/port 630 in the tip of the endoscope to createa closed system.

FIGS. 6I and 6J are illustrations of a system 620 for sterilizing anendoscope 600 using steam, in accordance with another embodiment of thepresent specification. FIGS. 6I and 6J illustrate the sterilizationsystem 620 comprising a steam generator 622 connected to at least onecompression fitting 623 by a length of tubing 624. In the embodimentshown in FIG. 6I the steam generator 622 is simultaneously connected topressure fittings 623 applied upon all the openings/ports provided on ahandle of the endoscope 600. In the embodiment shown in FIG. 6J, thesteam generator 622 is connected to a pressure fitting 623 applied uponone of the openings/ports 631 provided on a handle 632 of the endoscope600. Steam generated by the steam generator 622 travels through thetubing 624 and the compression fitting(s) 623 into the channels 628 ofthe endoscope 600. Pressure resistant fittings 625 cover the remainingports/openings 626, 627 the endoscope and the opening/port 630 in thetip of the endoscope 600 to create a closed system.

FIG. 7A is an illustration of a compression fitting for connecting witha control section of an endoscope, in accordance with one embodiment ofthe present specification. Compression fitting/plug 702 comprises a plugframe 704 comprising a protruding suction plug 706 and an air/water plug708. As shown, the suction plug 706 is used to plug the suction opening712 provided on a control section 710 or handle of an endoscope and theair/water plug 708 is used to plug the air/water opening 714. In variousembodiments, the suction plug 706 is inserted into the suction opening712 and the air/water plug 708 is inserted into the air/water opening714 on the control section 710 in order to seal off the endoscope fromthe outside, thereby providing a pressurized atmosphere within when asteam generator is used to fill the internal channels of the endoscopewith steam. In an embodiment, a steam generator may be coupled with thecompression fitting 702.

FIG. 7B is an illustration of a plurality of compression fittings toconnect a steam generator to an endoscope for sterilization, inaccordance with various embodiments of the present specification. Eachcompression fitting 720, 725, 730, 735, 740 and 745 is connected to alength of tubing 728 which in turn is connected to a steam generator. Inembodiments, the shape of each compression fitting 720, 725, 730, 735,740 and 745 is adapted according to a corresponding port of theendoscope being fitted with it Compression fitting 740 is designed forfitting over a control section of an endoscope such as described withreference to FIG. 7A.

FIG. 7C is an illustration of a compression fitting for connecting witha control section of an endoscope, in accordance with one embodiment ofthe present specification. Compression fitting/plug 740 comprises a plugframe comprising a protruding suction plug 742 and an air/water plug744. In some embodiments, the compression fitting 740 includes apressure resistant cover 746 for sealing off an opening of one of thechannels. The cover 746 is attached to the plug 740 via a length ofchain 745. The component 740 slides over the opening on the channels ofthe endoscope, locking the fitting 740 and 742 into the adjacent channelopenings of the endoscope.

FIG. 7D is an illustration of another compression fitting 750, inaccordance with one embodiment of the present specification.

FIG. 7E is an illustration of a plurality of compression fittingsconnected to an endoscope for sterilization of the same, in accordancewith various embodiments of the present specification. A compressionfitting 751 is shown fitted on the suction and air/water ports of ahandle of the endoscope 700. Compression fitting 751 is connected to asteam generator (not shown in FIG. 7E) via tubing 753. Anothercompression fitting 755 is connected to a biopsy port 757 of endoscope700. The compression fitting 755 may be connected to a steam generatorvia tubing 759 which may bifurcate into two tubing branches 759 a and759 b, wherein one of the tubing branches may be connected to acompression fitting applied on another port of the endoscope and theother tubing branch may be connected to a steam source.

FIG. 7F is an illustration of a plurality of compression fittingsconnecting a steam generator to an endoscope 700 for sterilization, inaccordance with various embodiments of the present specification. Acompression fitting 751 is shown fitted on the suction and air/waterports of a handle 763 of the endoscope 700. Compression fitting 761 isconnected to a tubing 765 which is connected to a steam generator (notshown in FIG. 7F) via a three way connector 767, tubing 769 and fitting771. Another compression fitting 773 is connected to a biopsy port ofendoscope 700. The compression fitting 773 is be connected to a steamgenerator via tubing 775 and fitting 777. FIG. 7G illustrates aconnector of an endoscope connected to a steam source for sterilizationprocess, in accordance with an embodiment of the present specification.A first port of the connector 779 is connected to a steam source via acompression fitting connected to a tubing 781 and fitting 783. A secondport 785 is connected to a steam source via a compression fitting 787,tubing 789 and fitting 791.

FIG. 8A is a flowchart listing the steps involved in a method of usingsteam to sterilize an endoscope, in accordance with one embodiment ofthe present specification. At step 802, manual cleaning of the endoscopeand its channel with a brush and scrub as per the manufacturer'srecommendation is performed. Cleaning of the endoscope (High LevelDisinfection) using the manufacturer recommended cleaning process isperformed at step 804. Then, at step 806, the endoscope is attached tothe steam generator via at least one of the ports using pressureresistant compression fittings. Pressure resistant fittings are attachedto the remaining ports to create a closed system at step 808. At step810, steam is delivered at a temperature greater than 100° C. and apressure greater than 0.1 MPa to sterilize or disinfect the endoscopechannels.

FIG. 8B is a flowchart listing the steps involved in a method of usingsteam to sterilize an endoscope, in accordance with another embodimentof the present specification. At step 812, manual cleaning of theendoscope and its channel with a brush and scrub as per themanufacturer's recommendation is performed. Then, at step 814, theendoscope is attached to the steam generator via at least one of theports using pressure resistant compression fittings. Pressure resistantfittings are attached to the remaining ports to create a closed systemat step 816. At step 818, steam is delivered a temperature greater than100° C. and a pressure greater than 0.1 MPa to sterilize or disinfectthe endoscope channels. Cleaning of the endoscope (High LevelDisinfection) using the manufacturer recommended cleaning process isthen performed at step 820.

FIG. 9A is an illustration of a pressure resistant fitting 901 includingan expandable membrane 903, in accordance with one embodiment of thepresent specification. Trapped air 909 in the channel 904 of theendoscope 900 can impair distribution of the steam within the channel,thereby interfering with the sterilization process. Hence, the air 909in the endoscope channel 904 should escape out of the channel 904without breaking the seal between the compression fitting 901 and theendoscope port 902 and allow the steam 907 to come in contact with thescope channel 904. To achieve that, an expandable membrane 903 isprovided coupled with the compression fitting 901 which divides thechamber in the pressure resistance fitting 901 into two compartments. Asthe steam 907 enters the channel 904, the air 909 in the channel 904 ispushed into a first compartment 911 out of the scope channel 904,expanding the membrane 903 and out into the second compartment 912making space for the additional air coming out of the endoscope channel904 into the first compartment 911. The second compartment 912 has anopening or a one way valve 905 to allow the air 909 in the secondcompartment 912 to escape, accommodating the expansion of the firstcompartment 911. The volume of the second compartment 912 is at least25% of the volume of the air 909 in the scope channel 904, and in anembodiment, the same volume as the air 909 in the scope channel 904 towhich it is attached.

FIG. 9B is an illustration of a pressure resistant fitting 901 connectedto a vacuum pump, in accordance with another embodiment of the presentspecification. To allow any air 909 trapped in the endoscope channel 904to escape upon passage of steam 907 in the channel 904 without breakingthe seal between the compression fitting 901 and the endoscope port 902,the fitting 901 is connected to a vacuum suction pump 913. As the steam907 enters the channel 904, the air 909 in the channel 904 is pushedinto the fitting 901 and is suctioned away 914 through an opening or oneway valve 905. After a specific duration of time, the vacuum pump 913shuts down while the steam 907 continues to enter the scope channel 904,increasing both its temperature and pressure until the desirableparameters for sterilization or disinfection are reached. After apredetermined time, the suction may be started again, for sucking thesteam from the channel 904 and decreasing both the channel 904 pressureand temperature. Alternatively, a temperature sensor 915 is providedcoupled to the fitting 901 for sensing the air temperature. As the airtemperature approaches a predetermined temperature, the vacuum pump 913is shut down. After the temperature is maintained at a desirable levelfor a desirable amount of time, the vacuum pump 913 may be started againfor removing the air 909 from the endoscope channel 904.

In various embodiments the various pressure relief valves are controlledby a microprocessor in a sequential fashion so as to ascertain adequatecirculation of the sterilizing or disinfecting agent.

FIG. 10A is a flowchart listing the steps involved in a method of usingsteam to sterilize an endoscope, in accordance with another embodimentof the present specification. At step 1002, manual cleaning of theendoscope and its channel with a brush and scrub per the manufacturer'srecommendation is performed. Cleaning of the endoscope (High LevelDisinfection) using the manufacturer recommended cleaning process isperformed at step 1004. Then, at step 1006, the endoscope is attached tothe steam generator via at least one of the ports using the pressureresistant compression fittings. Pressure resistant fittings are attachedto the remaining ports to create a closed system at step 1008, whereinat least one pressure resistant fitting includes a membrane toaccommodate air expansion in an endoscope channel. At step 1010, steamis delivered at a temperature greater than 100° C. and a pressuregreater than 0.1 MPa to sterilize or disinfect the endoscope channels.

FIG. 10B is a flowchart listing the steps involved in a method of usingsteam to sterilize an endoscope, in accordance with another embodimentof the present specification. At step 1012, manual cleaning of theendoscope and its channel with a brush and scrub per the manufacturer'srecommendation is performed. Then, at step 1014, the endoscope isattached to the steam generator via at least one of the ports using thepressure resistant compression fittings. Pressure resistant fittings areattached to the remaining ports to create a closed system at step 1016.At step 1018, steam is delivered at a temperature greater than 100° C.and a pressure greater than 0.1 MPa to sterilize or disinfect theendoscope channels. Suctioning of excess air or fluid out of theendoscope channel using a suction pump or vacuum, and then the cessationof suction, is performed at step 1020. The temperature and pressure inthe endoscope channel are allowed to rise to the desirable level and aremaintained at said level for the desired duration at step 1022. Cleaningof the endoscope (High Level Disinfection) using the manufacturerrecommended cleaning process is then performed at step 1024.

FIGS. 11A, 11B, and 11C are cross-sectional illustrations of endoscopes1100 depicting the pathway of steam 1105 during a sterilizationprocedure, in accordance with some embodiments of the presentspecification. As shown in FIG. 11A, a steam source may be connected toa port 1102 on a handle 1104 of the endoscope 1100 and by sealing offthe remaining ports of the endoscope, steam 1105 is caused to circulatethrough the endoscope's channel for a desired period of time forsterilizing the channels. Once the sterilization process is complete,the steam may leave the channels via a port 1106 provided on a connector1108 of the endoscope.

As shown in FIG. 11B, a steam source may be connected to an opening in atip 1110 of the insertion tube 1103 of the endoscope 1100 and by sealingoff the remaining ports of the endoscope, steam 1105 is caused tocirculate through the endoscope's channel for a desired period of timefor sterilizing the channels. Once the sterilization process is completethe steam may leave the channels via a port 1106 provided on a connector1108 of the endoscope.

As shown in FIG. 11C water, steam, H₂O₂, H₂O₂ plasma gas, or any othersterilization agent know in the art 1105 enters the endoscope channelsvia a port 1106 provided on a connector 1108 of the endoscope 1100 andcirculates through all of the scope's channels exiting at an opening inthe tip 1110 of the insertion tube 1103. In an embodiment, any suitabledisinfectant for disinfecting the endoscope channels may also be pushedin via port 1106. The ports on the handle 1104 are sealed off by using acompression fitting 1112.

FIG. 12 is a graph illustrating the relationship between time 1202,pressure 1204, and temperature 1206 for various stages of sterilizing anendoscope using steam, in accordance with some embodiments of thepresent specification. Sterilization 1208 occurs when the temperature ismaintained over 100° C. and pressure is maintained over 0.2 MPa for aspecific amount of time. In some embodiments, said amount of time rangesfrom 3 minutes to 60 minutes.

FIG. 13A is an illustration of a distal end of an endoscope used inEndoscopic Retrograde Cholangiopancreatography (ERCP) procedures. TheEndoscope also known in the art as duodenoscope comprises a wire channelalso known as an elevator channel 1305 for insertion of medicalinstruments within a patient's body cavity. In some available models,The ERCP endoscope's elevator 1305 wire channel is ‘sealed’ to preventits contamination with such bacteria and superbugs such ascarbapenem-resistant Enterobacteriaceae, or CRE. The ‘sealed’ elevatorwire channel 1305, or the ‘sealed’ distal hood or case at the ERCPendoscope's distal tip, can retain debris and infectious CRE(inaccessible to the disinfectant and cleaning brush) that aretransmitted to patients during subsequent ERCP procedures. In general,high-level disinfectants rapidly kill vegetative bacteria, such as CRE,if the disinfectant is not precluded from contacting the organism by thereusable instrument's physical design. However, in most casesconventional means of disinfecting and cleaning the elevator channel1305 prove to be inefficient and ineffective.

In various embodiments, the elevator channel may be efficiently andthoroughly cleaned and sterilized by the passage of steam through thechannel. FIG. 13B is an illustration of movement of an elevator 1305 atthe distal tip of an endoscope 1300 to allow for complete sterilization,in accordance with one embodiment of the present specification. Theelevator 1305 may be moved manually, by using a lever 1307 on the handle1306 of the endoscope 1300, or by a mechanism included in thesterilization system and configured to move the elevator 1305 duringsterilization. Movement of the elevator 1305 during sterilization allowssteam access to an elevator recess 1309 during sterilization forcomplete sterilizing.

FIG. 14A is an illustration of a thermally insulated casing orsterilization chamber 1450 for use with steam sterilization of anendoscope 1400, in accordance with one embodiment of the presentspecification. The chamber 1450 comprises two halves connected by hinges1452 wherein each half is lined on the inside with a thermallyinsulating liner 1451. A first half 1450 a of the chamber 1450 opens toreceive an endoscope 1400 in an endoscope well 1401 for sterilization.Male clasps 1453 connect with female clasps 1455 to keep the chamber1450 securely closed during sterilization. A steam generator 1422introduces steam, via a compression fitting 1423, into the endoscope1400. The steam travels along a pathway 1410 in the endoscope channelsto sterilize the endoscope 1400. A vacuum pump 1413 is attached by apressure resistant fitting 1424 to the endoscope to remove steam or anytrapped air from the endoscope channels via suction. A pressureresistant fitting 1425 prevents the steam from escaping the channels ofthe endoscope thereby protecting the electronic connections of theendoscope 1400 from high pressure steam. A microprocessor 1421 controlsboth the steam generator 1422 and the vacuum pump 1413 and causes thesteam to reach a therapeutic temperature and pressure.

FIG. 14B is an illustration of a thermally insulated casing orsterilization chamber 1450 for use with steam sterilization of anendoscope 1400, in accordance with another embodiment of the presentspecification. A steam generator 1422 delivers steam into a well 1401 inthe chamber 1450 holding the endoscope. The steam is free to followpathways 1410 in the channels of the endoscope and pathways 1411 aboutthe exterior of the endoscope 1400, existing in a space between the well1401 of the chamber 1450 and the endoscope 1400. Once the sterilizationprocess is complete, the steam is suctioned out via tubing 1428connected to a vacuum pump (not shown in FIG. 14B).

FIG. 14C is an illustration of a thermally insulated casing 1450 for usein steam sterilization of an endoscope 1400, in accordance with yetanother embodiment of the present specification. Steam 1407 from a steamgenerator 1422 is forced through the scope tip through a pressureresistant compression fitting 1423. Additional pressure resistantfittings 1425 are applied to all the remaining openings of the endoscope1400. One or all of the pressure resistance fittings have a pressurerelief valve 1426 which opens at a pressure lower than the desiredpressure for sterilization. As the steam 1407 is forced through theendoscope channels, the pressure builds up in the channels and, as itapproaches the relief pressure, the valve 1426 opens, allowing the steamto escape and then circulate around the endoscope 1400, sterilizing theoutside of the endoscope 1400.

FIG. 15 is a flowchart listing the steps involved in a method of using athermally insulated casing, or sterilization chamber, and steam tosterilize an endoscope, in accordance with one embodiment of the presentspecification. At step 1502, the endoscope is manually cleaned andwashed. The endoscope is placed in the well of the sterilization chamberat step 1504. Then, at step 1506, the outlet channels of the endoscopeare connected to a vacuum suction port. The sterilization chamber isclosed at step 1508. Steam is delivered to reach a therapeutictemperature and pressure controlled by a microprocessor at step 1510. Atstep 1512, pressure and temperature sensors in the well monitor thetemperature and pressure and provide data to the microprocessor. Oncethe desirable temperature and pressure is reached, the vacuum is turnedon to start suction of the air in the endoscope channels at step 1514,creating a circulation of steam from the well into the endoscopechannels and out through the suction port into the vacuum chamber,thereby releasing the pressure. At step 1516, the rate of suction andrate of steam delivery into the sterilization chamber are controlled bythe microprocessor to maintain the desired temperature and pressure forthe desired duration. Optionally, at step 1518, the steam sterilizationis combined with the manufacturer recommended high-level disinfection.After the sterilization cycle is complete, the suction continues untilall of the excess water is removed from the endoscope at step 1520.Then, at step 1522, the endoscope is cooled and hung in the closet todry.

FIG. 16 is an illustration of an endoscope 1600 capable of withstandinghigh temperatures involved with steam sterilization, in accordance withone embodiment of the present specification. All the components of theendoscope 1600 can withstand a temperature greater than 100° C. andpreferably greater than 150° C. In an embodiment, the skin 1601 of theendoscope, including the lining of the channels, is made with silicone,Teflon®, polyethylene terephthalate (PET), polypropylene,polybenzimidazole, or a thermoplastic polymer or any other material thatcan withstand temperatures greater than 100° C. and preferably greaterthan 150° C. The electronic components are also designed to withstand atemperature greater than 100° C. and preferably greater than 150° C.

In some embodiments of the present specification, a sterilization systemis provided wherein instead of the use of pressurized compressionfittings as described in the above embodiments, separate pressurizedchambers are used. The endoscope is placed in a casing in which separatechambers can be created by using separators which force the disinfectingagent from one chamber to the other through the endoscope's channelsbased on pressure differences between the various chambers. Theseparators are automated for opening and closing as an area of contactwith the outside of the endoscope is occluded from contact with thesterilizing agent. The separators are then removed before the outside ofthe endoscope goes through sterilization process.

FIG. 17A is an illustration of a thermally insulated casing 1700 orsterilization chamber or apparatus subdivided into two or more chambers1703, 1705, in accordance with one embodiment of the presentspecification. As shown, casing 1700 is divided into two chambers bymeans of separating component or separator 1702. Each of the channelopenings or ports of an endoscope 1701 placed in the casing 1700 for thepurpose of sterilization occupies one or more of the chambers 1703,1705. In embodiments, one or more of the chambers are pressurized withsteam which enters chamber 1703 of casing 1700 through first openings1704, 1706. The steam is pushed through one or more of the first ports1712 of the endoscope to pass through endoscope channels 1713 and outthrough second ports 1714. The steam then passes out of one or more ofthe second openings 1708, 1710 in chamber 1705, thereby circulating thesteam in and around the endoscope due to the pressure difference createdby the separator 1702 between the chambers 1703, 1705. In someembodiments, the pressure is greater in chamber 1703 relative to thepressure in chamber 1705 to cause the sterilizing agent to travel fromchamber 1703, through the endoscope channels 1713, and out throughchamber 1705. In embodiments, temperature sensors are provided in one ormore of the chambers to monitor the temperature in that chamber.Further, optional pressure sensors may also be provided in the chambersto monitor the pressure in that chamber. There is an optional outletprovided in one or more of the chambers to allow the air or vapor toexit the chamber. The opening 1704 and 1706 and the outlets 1708 and1710 are optionally controlled by a microprocessor to control thedelivery of sterilizing agent and maintain adequate contact time at theadequate parameters.

FIG. 17B is an illustration of a thermally insulated casing 1720 orsterilization chamber subdivided into two or more chambers, inaccordance with another embodiment of the present specification. Asshown, casing 1720 is divided into three chambers 1722, 1724 and 1726 byusing separating components or separators 1728 and 1730. In anembodiment, the separators 1728, 1730 are automated and may be removedduring the sterilization process, allowing the vapor/sterilizing agentflowing through the chambers 1722, 1724 and 1726 to mix to create auniform sterilization temperature and pressure on the outside of theendoscope 1732. The sterilizing agent is pushed in via a channel 1734 ofthe casing 1720 and into ports 1733 of the endoscope 1732 where itcirculates through the endoscope channels 1735 and exits, due to thepressure difference between chambers 1722, 1724, 1726 out of ports 1737or ports 1739 of the endoscope 1732 and out of channels 1736 or 1738 ofthe casing 1720. In some embodiments, the pressure is greater in chamber1726 relative to the pressure in chambers 1724 and 1726 to cause thesterilizing agent to travel from chamber 1726, through the endoscopechannels 1735, and out through chambers 1724, 1726.

In various embodiments, methods for agitating the sterilizing ordisinfecting agents in each of the chambers is provided to improve thesterilizing or disinfecting process by dislodging organic material fromthe surface of the endoscope. The method of agitation may include one ofmechanical agitation or sound waves.

FIG. 18 is a flowchart illustrating the steps of sterilizing anendoscope by using pressurized chambers, in accordance with anembodiment of the present specification. At step 1802 the endoscope isplaced in a casing comprising two or more chambers created by the use ofseparators within the casing, and each of the endoscope's ports oroutlets are placed in the respective chambers and the casing is sealedor locked. At step 1804, the separators are deployed to pressurize thediscreet chambers. At step 1806, vapor or a sterilizing agent isadministered under pressure in one of the chambers and passed into theother chambers through various channels in the endoscope. At step 1808,various pressure and temperature sensors provided in the chambersmonitor predefined parameters in each respective chamber and indicate ifadequate disinfection or sterilization conditions have been reached. Atstep 1810, once adequate disinfection or sterilization conditions havebeen reached for adequate duration (which may range from 3 minutes to 60minutes), the separators are removed creating a single chamber allowingfor uniform disinfection or sterilization conditions on the externalsurface of the endoscope. At step 1812, the various pressure andtemperature sensors monitor the predefined parameters to determine ifadequate disinfection or sterilization conditions have been reached foradequate time on the external surface. Next, at step 1814, once adequatedisinfection or sterilization conditions have been reached for adequatetime on the external surface of the endoscope, the sterilizing system isshut-off and the lock or seal of the casing is opened for removal of theendoscope.

The above examples are merely illustrative of the many applications ofthe system of the present invention. Although only a few embodiments ofthe present invention have been described herein, it should beunderstood that the present invention might be embodied in many otherspecific forms without departing from the spirit or scope of theinvention. Therefore, the present examples and embodiments are to beconsidered as illustrative and not restrictive, and the invention may bemodified within the scope of the appended claims.

We claim:
 1. An apparatus for disinfecting or sterilizing an endoscope,comprising: at least one pressure resistant compression fitting designedto be operably attached to one opening of an endoscope; a disinfectingor sterilizing agent generator capable of delivering a disinfecting orsterilizing agent and attached to said at least one pressure resistantcompression fitting via a length of tubing; at least one pressureresistant vacuum suction fitting designed to be operably attached toanother opening of an endoscope at one end and attached to a vacuumsuction at the other end; and a microprocessor operably attached to thedisinfecting or sterilizing agent generator and vacuum pump to controlthe rate of delivery of disinfecting or sterilizing agent and rate ofsuction.
 2. The apparatus of claim 1, further comprising additionaldisinfecting or sterilizing agent delivery ports for delivery ofdisinfecting or sterilizing agent into one of the other openings of theendoscope.
 3. The apparatus of claim 1, further comprising additionalsuction ports for suction of disinfecting or sterilizing agent from oneof the other openings of the endoscope.
 4. The apparatus of claim 1,further comprising sensors to measure at least one of a plurality ofparameters of the disinfecting or sterilizing agent and input measureddata into the microprocessor to control the delivery of disinfecting orsterilizing agent or rate of suction or both.
 5. The apparatus of claim1, wherein said microprocessor further comprises a user interface toinput operational data or to monitor the progress of disinfection orsterilization.
 6. The apparatus of claim 1 wherein the disinfecting orsterilizing agent is superheated steam and the disinfecting orsterilizing agent generator comprises a steam generator.
 7. Theapparatus of claim 1 wherein the disinfecting or sterilizing agent is atleast one of hydrogen peroxide or ionized plasma gel.
 8. An apparatusfor disinfecting or sterilizing an endoscope, comprising: a thermallyinsulating casing with at least one pressure resistant compressionfitting designed to be operably attached to one opening of an endoscope;adisinfecting or sterilizing agent generator capable of delivering adisinfecting or sterilizing agent and attached to said pressureresistant compressing fitting; at least one vacuum suction port operablyattached to the casing at one end and attached to a vacuum suction atthe other end to provide suction; and a microprocessor operably attachedto the disinfecting or sterilizing agent generator and vacuum pump tocontrol the rate of delivery of disinfecting or sterilizing agent andrate of suction.
 9. The apparatus of claim 8, further comprisingadditional disinfecting or sterilizing agent delivery ports for deliveryof disinfecting or sterilizing agent into one of the other openings ofthe endoscope and additional suction ports for the suction ofdisinfecting or sterilizing agent from one of the other openings of theendoscope.
 10. The apparatus of claim 8, further comprising at least onesensor to measure any one of a plurality of parameters of thedisinfecting or sterilizing agent and input measured data into themicroprocessor to control the delivery of disinfecting or sterilizingagent or rate of suction or both.
 11. The apparatus of claim 8, whereinsaid microprocessor includes a user interface to input operational dataor to monitor the progress of disinfection or sterilization.
 12. Theapparatus of claim 8 wherein the disinfecting or sterilizing agent issuperheated steam and the disinfecting or sterilizing agent generatorcomprises a steam generator.
 13. The apparatus of claim 8 wherein thedisinfecting or sterilizing agent is at least one of hydrogen peroxideor ionized plasma gel.
 14. An apparatus for disinfecting or sterilizingan endoscope, comprising: at least two chambers separated by aseparating component; a space for placing an endoscope wherein a firstportion of said endoscope comprising at least one first endoscope portis positioned in a first chamber of said at least two chambers and asecond portion of said endoscope comprising at least one secondendoscope port is positioned in a second chamber of said at least twochambers; at least one first opening providing fluid communicationbetween said first chamber and an outside area of said apparatus; and atleast one second opening providing fluid communication between saidsecond chamber and an outside area of said apparatus; wherein adisinfecting or sterilizing agent is introduced under pressure throughsaid first or second opening and into said first or second chamber andwherein a pressure difference between said first chamber and said secondchamber causes said disinfecting or sterilizing agent to enter saidendoscope through said first endoscope port or said second endoscopeport, pass through one or more endoscope channels of said endoscope,exit said endoscope through said first endoscope port or said secondendoscope port not comprising the endoscope port through which saiddisinfecting or sterilizing agent entered said endoscope, and exit saidapparatus through said first or second opening not comprising theopening through which the disinfecting or sterilizing agent entered saidapparatus.
 15. The apparatus of claim 14 wherein the disinfecting orsterilizing agent is superheated steam and wherein the apparatus furthercomprises a steam generator for introducing the superheated steamthrough said first or second opening.
 16. The apparatus of claim 14wherein the disinfecting or sterilizing agent is at least one ofhydrogen peroxide or ionized plasma gel.
 17. The apparatus of claim 14,further comprising additional endoscope ports positioned in the firstchamber, wherein the disinfecting or sterilizing agent is configured toenter or exit the endoscope through the additional endoscope ports. 18.The apparatus of claim 14, further comprising additional endoscope portspositioned in the second chamber, wherein the disinfecting orsterilizing agent is configured to enter or exit the endoscope throughthe additional endoscope ports.
 19. The apparatus of claim 14, furthercomprising sensors to measure at least one of a plurality of parametersof the disinfecting or sterilizing agent and input measured data intothe microprocessor to control the delivery of disinfecting orsterilizing agent or rate of suction or both.
 20. The apparatus of claim14, wherein said microprocessor further comprises a user interface toinput operational data or to monitor the progress of disinfection orsterilization.